Fermented foods have been known for millennia and form an important part of many national cuisines. Initially used primarily to preserve foods and improve their flavour, fermented foods are enjoying a resurgence in popularity due to improved understanding of the health benefits such foods can provide. Health benefits may result from compounds produced during the fermentation process, as well as the provision of “good bacteria”, which can contribute to a healthy digestive system. The renewed interest in fermented foods raises questions regarding how such foods, and the processes used to produce them, as well as newly discovered health benefits associated with such foods, can be protected. The present article focuses on the situation at the European Patent Office (EPO).
Patent protection for a fermented product or method at the EPO
When aiming to obtain patent protection for a new fermented food or product at the EPO, difficulty often arises around defining the fermented product, in particular where the new product has improved subjective characteristics (such as improved taste or smell), which are difficult to define clearly and in such a way that the product can be readily distinguished from other versions of the fermented product that are already known. Description of the improved product characteristics using “relative terms” such as the fermentation product having “improved/increased X”, should also be avoided as such terms are considered unclear unless a reference with which the claimed product is compared is stated in the claim. As improvements to fermented products are often the result of changes made to the fermentation process, such as differences in the fermentation conditions or microorganisms employed in the process, the key to defining the fermentation product clearly, especially where the difficulties mentioned above apply, therefore often lies in the fermentation process used to produce the product.
The EPO allows products to be defined in terms of a process of manufacture (so-called “product-by-process” claims) where it is impossible to define the product in another way. Such claims are interpreted as claims to the product “as such” and therefore cannot derive their novelty from the process used to make the product, i.e. the fermentation product itself must be new and inventive etc. in order for the product-by-process claim to be patentable. The burden is on the applicant to show that the fermentation process results in a fermentation product with novel characteristics which distinguish the product from known fermentation products. As it will not be possible to compare the fermentation product to all known fermentation products, a technical explanation regarding why the novel features of the fermentation process result in improved product characteristics in the specification is likely to be helpful, along with showing that the novel process features are not shared by known processes.
Novel fermentation processes which have been shown to have advantageous properties, such as producing fermentation products with improved product characteristics, can also be protected at the EPO. Claims granted to such processes furthermore extend protection to products directly obtained by the process. In Europe, a fermentation product can therefore be protected to some extent by seeking patent protection for the process instead, although care should be taken with regard to the ability to enforce such claims. In addition, as protection only extends to the direct product of the process, all of the process steps needed to arrive at the final commercial product should be described in the specification and included in the claims, even if these process steps are known or routine.
Where the novel process feature is, or includes, the use of a novel microorganism, the microorganism itself may also be eligible for patent protection, provided that it can be demonstrated that the microorganism provides a technical benefit, for example by providing an improvement regarding the operation of the fermentation process (such as the ability to perform the process at a lower temperature) or on the characteristics of the resulting fermentation product. This is the case regardless of whether the microorganism is novel due to genetic modification or is a naturally-occurring microorganism which has been isolated from its natural environment for the first time. For genetically modified microorganism, it may be possible to define the microorganism in terms of e.g. an exogenous gene introduced into the microorganism, and meet the requirements of clarity and sufficiency of disclosure. For naturally-occurring microorganisms, or genetically modified organisms for which the genetic changes giving rise to the improved characteristics are not clearly understood, the microorganism will need to be deposited with a depository institution recognised under the Budapest Treaty in order to be sufficiently disclosed. Whilst deposit of a microorganism may be a necessary measure to ensure sufficiency of disclosure, it should be borne in mind that once the patent application referring to the deposit has been published, the microorganism will be available to third parties for experimental purposes, or for any purpose (including commercial purposes) if the patent application is ultimately not granted or once the patent has lapsed or expired. Restrictions that can be placed on the furnishing of samples of deposited material to third parties are limited. Consequently, where the improvement to a fermentation product or process is provided by the use of a novel microorganism, and deposit of the microorganism is needed to meet the requirements of sufficiency of disclosure, it should be carefully considered whether applying for patent protection is appropriate under the circumstances, or whether it would be more appropriate to protect the microorganism as a trade secret.
Medical use claims
An invention may also lie in a newly discovered health benefit provided by a new or known fermentation product. Under these circumstances, the EPO allows medical use claims directed to the (known) fermentation product for use in a method of treatment. Although the EPO is prepared to grant such claims, care is needed to ensure that such claims provide useful protection, as the “treatment” referred to in the claim must match a health statement which may be made on a food product or additive under the European food labelling legislation. Involvement of the in-house regulatory team or suitable external experts during the patent drafting process is therefore advised.
In summary, the EPO provides a generous forum for protecting fermented products and fermentation processes, as well as new insights into their health-improving properties. However, close attention should be paid during the drafting process to ensure that basis for appropriate claim types and supporting information in the specification is provided, in particular in view of the EPO’s strict approach to added subject matter which limits to possibility for later amendments for which no explicit basis is provided in the application.
This article is a translation of the article published in JPPA’s monthly magazine “Patent”, June 2019.